Laparoscopic Transducer Cover UA0067

GUDID 00841436110297

Sterile (15.2 x 244cm) polyethylene telescopically-folded cover with attached form-fitting NeoGuard™

CIVCO MEDICAL INSTRUMENTS CO., INC.

Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover

• Primary Device ID: 00841436110297
• NIH Device Record Key: 81c5b253-885f-4ea8-8769-0b5631229988
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Laparoscopic Transducer Cover
• Version Model Number: UA0067
• Catalog Number: UA0067
• Company DUNS: 134614411
• Company Name: CIVCO MEDICAL INSTRUMENTS CO., INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com

Device Dimensions

• Length: 98 Inch
• Width: 6 Inch
• Length: 98 Inch
• Width: 6 Inch
• Length: 98 Inch
• Width: 6 Inch
• Length: 98 Inch
• Width: 6 Inch
• Length: 98 Inch
• Width: 6 Inch
• Length: 98 Inch
• Width: 6 Inch
• Length: 98 Inch
• Width: 6 Inch
• Length: 98 Inch
• Width: 6 Inch
• Length: 98 Inch
• Width: 6 Inch
• Length: 98 Inch
• Width: 6 Inch

Operating and Storage Conditions

• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841436110297 [Package]; Contains: 10841436110294; Package: [12 Units]; In Commercial Distribution
GS1	10841436110294 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013721

FDA Product Code

• ITX: Transducer, ultrasonic, diagnostic

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[00841436110297]

Ethylene Oxide

[00841436110297]

Ethylene Oxide

[00841436110297]

Ethylene Oxide

[00841436110297]

Ethylene Oxide

[00841436110297]

Ethylene Oxide

[00841436110297]

Ethylene Oxide

[00841436110297]

Ethylene Oxide

[00841436110297]

Ethylene Oxide

[00841436110297]

Ethylene Oxide

[00841436110297]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-09-06
• Device Publish Date: 2017-08-22

On-Brand Devices [Laparoscopic Transducer Cover]

• 00841436110297: Sterile (15.2 x 244cm) polyethylene telescopically-folded cover with attached form-fitting NeoGu
• 00841436104524: Sterile (15.2 x 244cm) telescopically-folded polyethylene cover with attached form-fitting NeoGu